Clinical Compliance Expert

7 days ago


Washington, Washington, D.C., United States Vision Achievement Full time
Job Description

Overview

Vision Achievement is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure.

Key Responsibilities

  • Plan and deliver Life Science consulting engagements related to quality/regulatory affairs infrastructure
  • Develop and implement quality systems planning and implementation, design control, and process validation
  • Conduct audits and assessments of design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
  • Develop and implement submissions, remediation, clinical evaluation, post-market surveillance, and risk management strategies
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements

Requirements

  • Bachelor's degree in Engineering, Science, or a Life Sciences-related field
  • Significant experience in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics
  • Experience with auditing design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
  • Experience with quality systems planning and implementation, design control, and process validation
  • Experience with submissions, remediation, clinical evaluation, post-market surveillance, and risk management

Travel

Ability to travel extensively domestically (25% - 50%). Occasional international travel may be required.



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